RU2593739C2 - System and method for traceability of surgical instrumentation system - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Surgical instrumentation system has a single-use instrument kit for fitting implants and at least one sterile implant kit. Each of said kits comprises an identifier, at least one of kits contains a unique identifier, as well as a medium for recording additional identifiers. One of additional identifiers is a patient code.

EFFECT: at least one other additional identifier is identifier of at least one complementary kit comprising an identifier transferable to additional-identifier recording medium, when complementary kit is used.

10 cl, 4 dwg

Description

Field of Invention

This invention relates to the field of management of surgical instruments and implants for single use and, in particular, orthopedic prostheses and related instruments.

State of the art

US Patent Application US 2003/0182299, known from the prior art, describes a system consisting of a plurality of sterile tool kits intended for placement of implants not included in the kits. Each set is marked with a unique identifier.

Also known patent application WO 03081379, which describes a solution for managing a unique kit containing surgical instruments and an intraocular implant.

This solution does not guarantee the control of surgical systems in which the instruments are located in one set and some implants in another, i.e. separated initially.

Also known documents DE 4420707, EP 1855264, WO 2005/027767 and WO 2011/035277 describing control markers and methods used in the field of medicine.

In addition, International Patent Application WO 2008/043921 is known which describes the procedure and routine control of medical devices in which the device itself and / or its packaging are marked and identified by the first link. This first link is stored in the first file. The product is delivered in packaged form for subsequent use by the consumer in the treatment of the patient specified in the second file. Product links open automatically and remotely upon delivery. These links are stored in the third consumer inventory file at the time of use of the product. A prior art solution provides for the automatic detection of an available product by inserting product links into a second file corresponding to the patient for whom the product is being used or will be used. Then the fourth file is installed, including partial links coming from the patient file and determining the links of the product for monitoring, and this fourth file is automatically or semi-automatically transferred to the supplier of the product.

The solutions proposed in the prior art have several technical disadvantages:

First, they necessarily require access to a digital information system to process and use identification data.

Under operating conditions, the use of a data processing tool is inappropriate and this leads to the registration of data before or after receiving information. Delaying this registration is a source of errors or omissions, which is detrimental to confidentiality in the control of products and tools used.

Secondly, the solutions proposed in the prior art provide, as in the case of patent application WO 2008/043921, registration in an information system identifying a patient. This restriction conflicts with the rules for maintaining the confidentiality of medical data and its management, although the regulatory and technical documentation of this product requires medical confidentiality when identifying the patient.

The solution proposed in patent application US 2003/0182299, on the contrary, does not provide communication between the patient and the surgical equipment and relates only to inventory management through a computer system.

Therefore, none of the solutions proposed in the prior art does not guarantee a complete control of medical institutions in full accordance with the rules regarding the anonymity of the patient. This omission is a problem, since not all persons involved in the monitoring of surgical instrument kits are medical professionals who are required to maintain the confidentiality of medical information.

In addition, none of the solutions proposed in the prior art does not guarantee the control of all instruments and implants used for a given patient.

The solution proposed in accordance with this invention

The purpose of this invention is to correct these shortcomings by introducing a simple system for using equipment that can be used in the strict context of the management of forensic data.

To this end, the invention relates, in General terms, to a control system for sets of surgical instruments, consisting of a set of instruments for single use when installing the implant and at least one sterile set of implants, each of the above sets includes an identifier, characterized in that at least at least one of the above sets of surgical instruments contains a unique identifier, as well as a storage medium for registering additional identifiers,

- one of the above additional identifiers is the patient code obtained during the use of the above set,

- at least one other additional identifier is an identifier of at least one additional set including an identifier transferred to the above information medium of the additional identifier while using the above additional set.

A surgical instrument kit may include one or more instruments or one or more implants, or one or more instruments and one or more implants.

In accordance with embodiments, the above unique identifier consists of a visually identifiable code or is registered in electronic memory.

According to a first preferred embodiment of the invention, the additional identifier information carrier consists of an identification sheet bearing the above unique identifier, as well as an area for receiving a portable identifier carrier and an area for obtaining a patient code (8).

According to a second embodiment of the invention, the additional identifier information medium consists of a computer file capable of obtaining the above unique identifier, a patient code and a portable identifier medium.

Mostly the patient code is anonymous and non-unique.

In accordance with an embodiment, the control system for sets of surgical instruments, in accordance with the invention, also includes a database for recording information regarding the manufacture, packaging and sterilization of all sets, the system also includes means for comparing information from the information carrier of an additional identifier from a unique the identifier associated with the above medium.

Advantageously, the surgical instrument set includes the above unique identifier, and the above information carrier is the corresponding tool set.

The invention also relates to a method for monitoring surgical instrument kits consisting of a disposable instrument kit for implant placement and at least one sterile implant kit, and each of the aforementioned kits includes an identifier, the method being different in that the patient code is recorded on an additional identifier information carrier associated with one of the above sets, including a unique identifier, and, in addition, at least one portable identifier the at least one complementary set catalyst is registered on the above additional identifier information carrier while using the above complementary set.

In accordance with one embodiment, the method includes the step of transferring the above information medium to the database of collected data at the final stage of using the above system in a patient, since this includes at least the step of editing the final file of the collected data.

In accordance with another embodiment, the method includes the step of transferring to the controller the waste to be disposed of, an operational control file, grouping together information from the registration file.

Detailed description of an embodiment of the invention

The invention will be better understood by studying the following description related to non-limiting embodiments, which are illustrated in the accompanying drawings, where:

- figure 1 shows a schematic representation of kits for implementing the invention;

- figures 2 and 2b show images of the kit after opening the package, as well as associated identifiers;

- figure 3 shows an example of an additional identifier information carrier;

- figure 4 shows an image of information flows during the implementation of the invention.

Detailed Description of a Preferred Embodiment

The control system for surgical instrument kits in accordance with the invention consists of several disposable kits, for example, kits comprising one or more appropriate instruments packaged in sterile conditions, and kits comprising one or more sterile prostheses or implants designed to equip the instruments of the first recruitment.

Use cases for single use kits

The prior art in the field of spinal surgery consists of the manufacture of implants and tool kits available to surgeons. Some companies specializing in this field offer implants packaged in sterile conditions that are ready for use.

Also known are examples of re-use of tool kits, if necessary, after disinfection and sterilization, which leads to many problems:

- after cleaning, however, there is a high risk of infection from one patient to another;

- disinfection and sterilization in accordance with regulatory documents causes great difficulties due to complex forms with numerous cavities on the instruments;

- These stages are associated with the high responsibility of medical institutions, as well as the high costs of both human and material resources.

Loss, breakage, wear and damage to the instrument can be detrimental to the next patient or even cause the operation to be canceled. The logistics area also includes numerous inconveniences, difficult and costly for both the manufacturer and the medical facility, and usually involves high material costs.

Therefore, the speed of recruitment between medical institutions and the material and technical service of the manufacturer is multiple, which significantly increases the risk of loss and error. The invention thus takes into account the safety aspect for both the patient and the surgeon, as well as the financial, human and material aspects of medical facilities.

An example of spinal surgery kits

The invention is further described with respect to the pedicle screw system presented in French patent application FR 09/06369.

The system consists of several single-use kits:

- a tool kit, which is a "one-time use tool kit for implant placement (1)", which includes all the tools necessary for preparing and installing the implant in the spine and fixing the structure. This set insures the surgeon with the use of new tools at every intervention, eliminates any risks of nosocomial infection and can significantly reduce healthcare costs;

- sterile sets of implants (2, 3), which are formed from:

- an implant kit (2), which includes a transpedicular screw and its plug, pre-installed on appropriate instruments, which is convenient for use. This set is identified in several references: screw diameter and length options;

- a set of pins (3), including two connecting pins.

Figures 2 and 2b show the views of the sets of implants (2) and instruments (1), respectively, after opening the package, as well as associated identifiers.

Tool kits (1) contain a unique identifier (4), which allows to use this surgery (patient file) with other used kits (2, 3) (pins or screws) when used in the operating room. This unique identifier (4) can be a sequential batch number, a barcode of a matrix code of the "data matrix" type, a code registered in electronic memory or on any other media.

In each set of implants (2, 3), in accordance with the instructions, there are several portable tags (labels, stickers, tags) (5, 6) to ensure complete control of the content.

The information carrier, consisting of a paper control file, is supplied in an instrumental set containing its unique identifier (4), which allows to realize all marks (5) of the “implant” used during surgery, as well as to encode information about the corresponding patient (encoding for privacy reasons). This coding mainly has a “non-unique” type, for example, the first three characters of the patient’s name or even the date of intervention without specifying the time. This ensures that there is no risk of breach of medical confidentiality.

Transferred labels (5) are self-adhesive labels on which an identifier is printed, for example, the production lot number. This identifier is not necessarily unique, but it must be specific to the same component coming from the same production series.

Additional identifier information carrier

Figure 3 shows an example of an additional identifier information carrier (7).

This identification sheet (7), included in one of the sets, for example, described in the tool kit (1), is used, firstly, in a medical institution to fill out a patient file and, secondly, to facilitate billing and replenishment of sets as well as to enable disposable tools to be disposed of.

For this purpose, areas for attaching marks (5, 6) removed from the sets of implants (2, 3) during their use are intended.

This identification sheet is issued as an example to ensure:

- Anonymous patient identification, which allows the medical institution to identify the patient without revealing confidential information to other participants in the delivery of equipment, and also eliminates the possibility of re-use of instruments for one-time use;

- declarations of the danger of contracting an infectious disease: medical institutions announce the danger of contracting an infectious disease if the patient is infected with HIV infection, Creutzfeldt-Jakob disease, etc.

- when using an identifier from other sets.

This identification sheet is sent to the operator, who enters the information into the database. The database is filled in such a way as to initiate invoicing, re-purchase of instruments and disposal of used instruments, as well as the transfer of a final sheet containing all control information received from the medical institution, from the instrument manufacturer, packer and from the organization providing sterilization.

This identification sheet (7) can be directly filled through an online database.

Figure 4 shows a schematic representation of information flows.

An information element of a link type consists of a unique identifier (4) associated with a set of tools (1), as well as with a storage medium (7) that is contained therein.

After opening the package of the kit (1) for surgical intervention, anonymous information (8) that is not directly related to the patient is recorded on the information carrier (7), for example, by writing the code (8) in the header (9). This code (8) may consist of the first three letters of the patient’s name. This trigram is not unique, since several surnames can begin with the same character sequence, for example, the “DEP” trigram, meaning both “Claude DEPIPEAU” and “Marcel DEPUY”. Therefore, the code generated by this trigram does not in itself provide the possibility of patient identification and its transfer does not contradict the rules of medical confidentiality.

Only a medical institution can provide a link between the patient, his full identification and the control sheet (7). To this end, the medical institution will correlate the unique identifier (4) from the tool kit (1) with the file that belongs to the patient, or record on a duplicate identification sheet (7) of the patient’s unique identifier, the duplicate that will be stored in the archive of the medical institution.

In particular, the tool kit (1) may include a self-adhesive label on which a unique identifier or portable storage medium is printed in order to facilitate the association of this identifier with the patient file.

Thus, the medical institution will have available:

- patient file compiled in accordance with the rules of maintaining medical confidentiality;

- anonymous control file;

- unique information generated by a unique identifier and a non-unique patient code that allows you to compare the patient file with the control sheet (7).

On the other hand, the manufacturer does not have a patient file, and the patient code attached to the control file (7) under any circumstances allows him to identify the necessary patient.

During surgery, the surgeon selects one or another of the sets of implants (2, 3) necessary for the surgical operation during its implementation. Each of these sets (2, 3) includes identifiers that may be common to several sets in the same series. For example, several sets of pins include the same identifier (XYZ) for those in the first series, and (MNO) for those in the second series. In addition, these identifiers (5, 6) are printed on the self-adhesive label contained in the packaging of the implant.

The label of the used set is separated from the set and transferred to the identification sheet (7).

At the end of the surgery, the identification sheet (7) is transmitted to the controller (10), for example, to the distributor or manufacturer of the sets, by fax, in the form of digital image files or mail, or by means of a mobile phone equipped with a camera.

The controller (10) writes all the information to the control file (7) and, where applicable, compares it with the information received from the manufacturer (11), including data, where applicable, regarding packaging and sterilization.

Then, the controller can retransmit to the medical institution (12) an identification sheet identified by a combination of a unique identifier and an anonymous code (8) of the patient and including information about the status of each of the instruments and implants, in accordance with the identifiers registered on the control sheet (7).

Then, in the medical institution, this identification sheet can be associated with a patient file, which only this institution has the right to use and compare, since only the medical institution can store information that allows the non-unique code (8) to be associated with the patient’s secret identifier, using a unique identifier (4 ) from the toolbox.

Option for waste management

Currently, disposable products that are commonly used are treated as waste in the healthcare system at risk of infection, disposed of in special containers, and then incinerated.

Packages of medical devices in accordance with the invention are designed to then serve as packaging for disposal.

After the operation, the medical institution announces the use of the device by entering the patient sheet in the database, which, as described above, initiates the purchase of new products, and also provides the possibility of disposal.

If the patient does not have any infectious disease (HIV, Creutzfeldt-Jakob disease, etc.), the product is disinfected in a medical facility and placed again in its packaging. The manufacturer is identified by a unique batch number and / or label (self-adhesive label, etc.), the product is stored in a medical facility until the manufacturer picks it up.

At the same time, these items are inventoried in the database as items that will be processed; if the patient is sick (HIV, Creutzfeldt-Jakob disease, etc.) or has symptoms without a diagnosis, without the ability to control immediately after surgery, the products are burned according to the procedures of a medical institution.

The manufacturer draws up a recycling dossier when processing a database that contains initial production information and an identification sheet, and organizes the collection of parts of products. The products are physically sent to the places of processing responsible for the cleaning and sorting of materials, and their processing, whatever they may be.

Claims (10)

1. The control system of sets of surgical instruments, consisting of a set of disposable instruments for implant placement (1) and at least one sterile implant set (2, 3), each of the above sets includes an identifier, characterized in that at least one of the above sets contains a unique identifier (4), as well as a storage medium for registering additional identifiers,
- one of the above additional identifiers is the patient code obtained during the use of the above set,
- at least one other additional identifier is an identifier of at least one additional set (2, 3) including an identifier (5, 6) transferred to the above information carrier for registering additional identifiers (7) while using the above additional set. 2. The control system for sets of surgical instruments according to claim 1, characterized in that the above unique identifier (4) consists of a visually recognizable code. 3. The control system for sets of surgical instruments according to claim 1, characterized in that the above unique identifier (4) consists of a code registered in electronic memory. 4. The control system for surgical instrument kits according to any one of the preceding paragraphs, characterized in that the information carrier for registering additional identifiers (7) consists of an identification sheet bearing the above unique identifier, as well as areas for receiving a portable identifier carrier and areas for obtaining a patient code . 5. The control system of sets of surgical instruments according to any one of paragraphs. 1-3, characterized in that the storage medium for registration of additional identifiers (7) consists of a computer file capable of receiving the above unique identifier, patient code and portable identifier medium. 6. The control system of sets of surgical instruments according to any one of paragraphs. 1-3, characterized in that it further includes a database for recording information regarding the manufacture, packaging and sterilization of all sets, as well as means for comparing information from the information carrier for registering additional identifiers (7) using a unique identifier associated with the above carrier. 7. The control system of sets of surgical instruments according to any one of paragraphs. 1-3, characterized in that the kit includes the above unique identifier, and the above storage medium (7) is the corresponding set of tools. 8. A method for monitoring sets of surgical instruments, consisting of a set of disposable instruments for implant placement and at least one sterile set of implants, each of the above sets includes an identifier, characterized in that the patient code is recorded on the information carrier to register additional identifiers ( 7) associated with one of the above sets comprising a unique identifier and at least one portable identifier of at least one an additional set is also registered on the above information carrier for registering additional identifiers (7) while using the above additional set. 9. A method for monitoring sets of surgical instruments according to claim 8, characterized in that it includes the step of transferring the above information carrier to the information database at the final stage of using the above system in a patient, and at least the step of editing the final file of the collected data. 10. The method of controlling the sets of surgical instruments according to claim 8, characterized in that it includes the step of transferring to the controller the waste to be disposed of, and the identification sheet contains information from the information carrier for registering additional identifiers (7).

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